Laboratory experts from the BioMed Alliance IVD Working Group released a new statement highlighting a looming threat for the diagnostic sector: the slow implementation of the new In Vitro Diagnostic Regulation (IVDR). They argue that urgent actions are necessary now to prevent a collapse of the diagnostic sector.

The application date of the new In Vitro Diagnostics Regulation is only one year away (26 May 2022) and there are widespread concerns that the implementation is not progressing quickly enough and that the diagnostic sector is not ready. The new regulation proposes stricter safeguards for tests and additional elements in the regulatory framework for IVD tests, but so far, its implementation has been slow. As a result, not all elements and guidance are in place, making it harder for the diagnostic sector to prepare.

The BioMed Alliance has provided an overview of the implementation process and the steps to take and hopes that the issue will feature high on the EU agenda so pressing questions can be addressed.

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